Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab
Trial Parameters
Brief Summary
Aim of the study is to evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients.
Eligibility Criteria
Key Inclusion Criteria 1. Patient's signed informed consent 2. Age ≥18 years at time of signing Informed Consent Form 3. Ability to comply with the study protocol, according to investigator's judgement 4. Life expectancy of at least 12 weeks 5. HCC with histologically confirmed diagnosis 6. Disease that is not amenable to curative surgical and/or local ablation but eligible for TACE 7. ECOG Performance Status of 0 or 1 8. Child-Pugh class A or B7 9. Adequate hematologic and end-organ function 10. Negative HIV test at screening Key Exclusion Criteria 1. Diffuse HCC or presence of vascular invasion or extrahepatic spread or more than 7 lesions or at least one lesion \>= 7 cm 2. Clinically relevant ascites 3. Uncontrolled pleural effusion or pericardial effusion 4. History or presence of hepatic encephalopathy 5. Co-infection of HBV and HCV 6. Patients on a liver transplantation list. 7. Prior systemic therapy for HCC 8. Prior treatment with TACE or selective internal radiation treatment